Phase 1 study of oral panobinostat in patients with cancer
Research type
Research Study
Full title
A phase I, open-label, multicenter study to evaluate the pharmacokinetics and safety of oral panobinostat in patients with advanced solid tumors and various degrees of hepatic function.
IRAS ID
40576
Contact name
Sally Clive
Sponsor organisation
Novartis Pharma AG
Eudract number
2009-012262-31
Clinicaltrials.gov Identifier
Research summary
The purpose of this phase 1 research study is to study the effects of liver function on the breakdown (metabolism) of an experimental drug called panobinostat. The research will also help to find out more about the side effects and potential beneficial effects of panobinostat in people who have advanced cancer with varying degrees of liver dysfunction. Adults with relapsed advanced cancer are invited to participate. Eligible participants will be classified into 4 groups according to their current liver function, ranging from normal to severely impaired function. Initially, only patients with normal, mild or moderately impaired liver will be enrolled. A decision to enroll patients with severe liver impairment will be made following a safety review of data from the initial patient group. The study has 2 phases: Core and Extension. Following a screening period of up to 4 weeks, eligible participants will start the Core (study) Phase (days 1-7). During this core phase participants will take one dose of oral panobinostat on Day 1 followed by a 5-day evaluation period including daily blood tests to investigate the breakdown of panobinostat. The Extension (treatment) Phase starts on Day 8 of study cycle 1: on Day 8, participants will start taking panobinostat once a day three times a week, every week (eg. Monday, Wednesday, Friday) until day 28. After cycle 1, 28 day treatment cycles will continue until disease progression, unacceptable toxicity (side effects) or withdrawal of consent. Participants will return to the clinic at regular intervals throughout the study for safety checks including blood samples, ECGs and physical examinations with assessment of cancer growth every 2 months. Each visit should take about 1-3 hours. About 32 patients will participate; only one site is based in the UK, the others are in different countries including Sweden and the USA. This trial is sponsored by Novartis Pharma AG.
REC name
London - Chelsea Research Ethics Committee
REC reference
10/H0801/11
Date of REC Opinion
31 Mar 2010
REC opinion
Further Information Favourable Opinion